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Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)

Primary Purpose

Warts, Genital, Neoplasms, Anal

Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
V503
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Warts, Genital

Eligibility Criteria

16 Years - 26 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Is a Japanese male 16 to 26 years of age
  • Has no more than 5 lifetime sexual partners

Exclusion Criteria:

  • Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study
  • Has a history of external genital warts
  • Has a history of severe allergic reaction that required medical intervention
  • Has received immune globulin or blood-derived products in the past 3 months or plan to receive any before Month 7 of the study
  • Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
  • Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
  • Has a known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
  • Has ongoing alcohol or drug abuse within the past 12 months

Sites / Locations

  • Umeyama Clinic ( Site 6406)
  • Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424)
  • Ocean Clinic ( Site 6407)
  • Kanno Clinic ( Site 6402)
  • P-One Clinic, Keikokai Medical Corp. ( Site 6419)
  • Iwasa Clinic ( Site 6411)
  • Nomura Clinic Namba ( Site 6405)
  • Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409)
  • Yamanaka Clinic ( Site 6410)
  • Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404)
  • Yuge Clinic ( Site 6421)
  • Taisei Clinic ( Site 6403)
  • Mildix Skin Clinic ( Site 6423)
  • Sugisawa Dermatology Clinic ( Site 6422)
  • Medical Corporation Sanshikai Toru Clinic ( Site 6401)
  • Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418)
  • Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416)
  • Naoko Dermatology Clinic ( Site 6417)
  • Medical Corporation Iseikai My City Clinic ( Site 6414)
  • Shinjuku Higashiguchi Clinic ( Site 6415)
  • Ogikuboekimae Clinic ( Site 6413)
  • Kusunoki Clinic ( Site 6412)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

V503

Placebo

Arm Description

Participants receive an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.

Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.

Outcomes

Primary Outcome Measures

Combined incidence of HPV 6/11/16/18-related anogenital persistent infection
This endpoint is defined to have occurred in a participant 1) who is polymerase chain reaction (PCR) positive to HPV 6, 11, 16 or 18 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of this endpoint is assessed in each treatment arm.
Percentage of participants with solicited injection-site adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants with ≥1 systemic AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants with ≥1 serious adverse events (SAEs)
An SAE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is an other important medical event.

Secondary Outcome Measures

Combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection
This endpoint is defined to have occurred in a participant 1) who is PCR positive to HPV 31, 33, 45, 52, or 58 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 31, 33, 45, 52, or 58 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of this endpoint is assessed in each treatment arm.
Geometric mean titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58
Serum antibody titers are measured with a competitive Luminex immunoassay (cLIA).

Full Information

First Posted
November 5, 2020
Last Updated
October 6, 2022
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04635423
Brief Title
Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)
Official Title
A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9vHPV Vaccine in Japanese Males, 16 to 26 Years of Age.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) in preventing HPV-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts, Genital, Neoplasms, Anal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V503
Arm Type
Experimental
Arm Description
Participants receive an intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.
Intervention Type
Biological
Intervention Name(s)
V503
Other Intervention Name(s)
9vHPV vaccine, SILGARD®9, GARDASIL™9
Intervention Description
9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 virus-like particle (VLP) 30/40/60/40/20/20/20/20/20 mcg per dose.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride (NaCL)
Primary Outcome Measure Information:
Title
Combined incidence of HPV 6/11/16/18-related anogenital persistent infection
Description
This endpoint is defined to have occurred in a participant 1) who is polymerase chain reaction (PCR) positive to HPV 6, 11, 16 or 18 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of this endpoint is assessed in each treatment arm.
Time Frame
Up to 42 months
Title
Percentage of participants with solicited injection-site adverse events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to 5 days after injection
Title
Percentage of participants with ≥1 systemic AE
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to 15 days after injection
Title
Percentage of participants with ≥1 serious adverse events (SAEs)
Description
An SAE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is an other important medical event.
Time Frame
Up to 6 months postdose 3 (up to 12 months)
Secondary Outcome Measure Information:
Title
Combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection
Description
This endpoint is defined to have occurred in a participant 1) who is PCR positive to HPV 31, 33, 45, 52, or 58 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 31, 33, 45, 52, or 58 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of this endpoint is assessed in each treatment arm.
Time Frame
Up to 42 months
Title
Geometric mean titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58
Description
Serum antibody titers are measured with a competitive Luminex immunoassay (cLIA).
Time Frame
Month 7

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is a Japanese male 16 to 26 years of age Has no more than 5 lifetime sexual partners Exclusion Criteria: Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study Has a history of external genital warts Has a history of severe allergic reaction that required medical intervention Has received immune globulin or blood-derived products in the past 3 months or plan to receive any before Month 7 of the study Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids Has a known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections Has ongoing alcohol or drug abuse within the past 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Umeyama Clinic ( Site 6406)
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0826
Country
Japan
Facility Name
Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Ocean Clinic ( Site 6407)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-8331
Country
Japan
Facility Name
Kanno Clinic ( Site 6402)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
590-0024
Country
Japan
Facility Name
P-One Clinic, Keikokai Medical Corp. ( Site 6419)
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0071
Country
Japan
Facility Name
Iwasa Clinic ( Site 6411)
City
Osaka
ZIP/Postal Code
542-0073
Country
Japan
Facility Name
Nomura Clinic Namba ( Site 6405)
City
Osaka
ZIP/Postal Code
542-0076
Country
Japan
Facility Name
Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409)
City
Osaka
ZIP/Postal Code
542-0086
Country
Japan
Facility Name
Yamanaka Clinic ( Site 6410)
City
Osaka
ZIP/Postal Code
553-0001
Country
Japan
Facility Name
Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404)
City
Tokyo
ZIP/Postal Code
101-0041
Country
Japan
Facility Name
Yuge Clinic ( Site 6421)
City
Tokyo
ZIP/Postal Code
103-0014
Country
Japan
Facility Name
Taisei Clinic ( Site 6403)
City
Tokyo
ZIP/Postal Code
107-0052
Country
Japan
Facility Name
Mildix Skin Clinic ( Site 6423)
City
Tokyo
ZIP/Postal Code
120-0034
Country
Japan
Facility Name
Sugisawa Dermatology Clinic ( Site 6422)
City
Tokyo
ZIP/Postal Code
125-0041
Country
Japan
Facility Name
Medical Corporation Sanshikai Toru Clinic ( Site 6401)
City
Tokyo
ZIP/Postal Code
132-0011
Country
Japan
Facility Name
Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418)
City
Tokyo
ZIP/Postal Code
144-0051
Country
Japan
Facility Name
Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416)
City
Tokyo
ZIP/Postal Code
154-0024
Country
Japan
Facility Name
Naoko Dermatology Clinic ( Site 6417)
City
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Facility Name
Medical Corporation Iseikai My City Clinic ( Site 6414)
City
Tokyo
ZIP/Postal Code
160-0022
Country
Japan
Facility Name
Shinjuku Higashiguchi Clinic ( Site 6415)
City
Tokyo
ZIP/Postal Code
160-0022
Country
Japan
Facility Name
Ogikuboekimae Clinic ( Site 6413)
City
Tokyo
ZIP/Postal Code
167-0051
Country
Japan
Facility Name
Kusunoki Clinic ( Site 6412)
City
Tokyo
ZIP/Postal Code
175-0092
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)

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